Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03455985
• Other study ID #: 2017H0354
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 11, 2020

Study information

• Verified date: July 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.

Description:

In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 diabetes and poor glycemic control (HbA1c >8.5%) will receive standard of care insulin therapy including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 222 patients (type 2 diabetes) will be recruited. Hospitalized patients with type 2 diabetes (HbA1c >8.5%) who are receiving basal insulin at least 10 unit per day and are able to provide informed consent and complete study procedures will be approached. All patients will be discharged on glargine U300 with initial doses determined by the discharging team. Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Patients will have follow-up phone calls at week 2, 6, and in-person visits at week 12 and 24. Phone calls will assess adherence with instructions for self-titration in the DOS group but are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. The study and all study-related documents will be approved by the OSU IRB. All data analyses will be completed as intention to treat analyses. Longitudinal outcomes (e.g., HbA1c) will be analyzed using mixed models utilizing all available measurements from individuals randomized.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of diabetes, type 2 =3 months duration

• HbA1c >8.5%

• Ages 25-75 years

• Phone or electronic media availability

• Receiving basal insulin >10 unit/day

Exclusion Criteria:

• Sensitive admissions: Prisoners

• Pregnancy

• Unable to consent or follow study directions in English

• Expected nursing facility stay longer than 2 weeks

Related Conditions & MeSH terms

• Blood Glucose, High
• Blood Glucose, Low
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Patient Discharge

Intervention

Other:
• Discharge Order Set (DOS)
In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.
• Enhanced Standard Care (ESC)
Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline to 24 Weeks	We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.	24 weeks
Secondary	Change in HbA1c From Baseline to 12 Weeks	We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 12 weeks change in Hb1Ac.	12 weeks
Secondary	Proportion Using Insulin Glargine U300 at 24 Weeks	proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.	24 weeks
Secondary	Fasting Glucose	We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model.; reported measure differs from original plan due to lack of fasting glucose in hospitalized patients.	24 weeks

External Links

•   Healthcare Cost and Utilization Project. Economic and Health Costs of Diabetes
•   Toujeo prescribing instructions